By Stewart Eisenhart, Emergo Group New draft guidance from the Health Sciences Authority (HSA), Singapore’s medical device market regulator, has issued new draft guidance expanding grouping criteria for medical and in vitro diagnostic devices submitted for registration. The guidance comprises two documents, one on general grouping criteria applicable to all devices submitted for HSA registration […]
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Coatings2Go is issued U.S. patent for hydrophilic coating
Coatings2Go, a medical device coating supplier for the medical device industry, announced its receipt of a patent as it relates to hydrophilic coatings. The U.S. Patent Office has issued to Coatings2Go a patent with a grant date of July 14, 2015: U.S. Patent Number 9,080,061, “Coating Resins And Coatings With Multiple Crosslink Functionalities.” “This new […]
Ten Steps to Comply with FDA UDI Requirements
By David Lennarz, Vice President and Co-Founder of Registrar Corp The September 24, 2015 Unique Device Identifier (UDI) compliance date is quickly approaching. Life-supporting and life-sustaining device labelers, as well as most contact and intraocular lens labelers, have only two months left to comply with the U.S. Food and Drug Administration’s (FDA) UDI labeling and […]
EU Publishes New List of Standards for Medical Device Directives
By Stewart Eisenhart, Emergo Group European officials have published an updated list of recognized and harmonized standards in the Official Journal of the European Union, including standards pertaining to their medical device and IVD Directives. The first 50 pages of the new list deal with the Medical Devices Directive, In Vitro Diagnostics Directive and Active […]
Improving marrow transplants through an unlikely source
by Nancy Fliesler Bone marrow transplantation, a.k.a. stem cell transplantation, can offer a cure for certain cancers, blood disorders, immune deficiencies and even metabolic disorders. But it’s a highly toxic procedure, especially when a closely matched marrow donor can’t be found. Using stem cells from umbilical cord blood banked after childbirth could open up many more matching […]
European Guidance on IFU for Sterilizing Medical Devices
By Ronald Boumans, Emergo Group The enforcement unit of the Competent Authorities overseeing medical device market surveillance in the European Union has published new guidance for Instructions for Use (IFU) for reusable and resterilizable medical devices following several non-conformities reported across member states. The Compliance & Enforcement Working Group of the European Commission (COEN), which issued the […]
Emergo Podcast: Medical Device Distribution in the Middle East
By Stewart Eisenhart, Emergo Group An effective medical device distribution plan for the Middle East requires appreciation for business culture and practices unique to the region, as well as for distinct market characteristics for countries such as Turkey, the Kingdom of Saudi Arabia and Egypt. In this podcast, Emergo Managing Director for the Middle East […]
Patient generated healthcare data
By John D. Halamka, MD I’ve often written about the IT strategies of Accountable Care Organizations and the need for a Care Management Medical Record which incorporates EHR data, patient generated data, customer relationship management features, protocols/guidelines and a workflow engine. Although I have yet to see mature products in the marketplace, components are evolving that will fundamentally change […]
FDA Voice: Improving Access to Medical Devices: FDA Uses Existing Clinical Data to Reduce Premarket Data Needs
By: Ben Fisher, Ph.D. At the FDA, we recognize the value of encouraging medical device innovation. We recently have acted to reduce the time and cost of clinical trials while maintaining patient protections. By doing so, FDA is helping to ensure that manufacturers will be more likely to conduct their clinical studies in the U.S., […]
South African authorities publish additional draft regulations for medical devices
By Stewart Eisenhart, Emergo Group South Africa’s Department of Health has released new draft regulations for medical devices and IVDs that accompanies proposed rules issued by the government in 2014.
Inverting the clinical trial/physician relationship: The future (and data) is in the practice
By Mark Vermette Traditionally, in the pharmaceutical and biotech worlds, a pharma company finds a candidate product and works with a group of doctors to test that product under careful standards and procedures. If the product shows therapeutic value and safety, it becomes available to prescribers to administer to patients for that purpose. The roles […]